NCT00900939

Brief Summary

The purpose of this study is to determine if a low-fat, vegan diet affects the number of acne lesions, acne severity, and acne extent.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

August 7, 2012

Status Verified

August 1, 2012

Enrollment Period

4 months

First QC Date

May 11, 2009

Last Update Submit

August 6, 2012

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

  • Number of acne lesions

    16 weeks

Secondary Outcomes (3)

  • Diet acceptability and adherence

    16 weeks

  • Acne severity and extent

    16 weeks

  • Quality of life

    16 weeks

Study Arms (2)

Low-fat, vegan diet

EXPERIMENTAL
Behavioral: Low-fat, vegan diet

Control

PLACEBO COMPARATOR
Behavioral: Control

Interventions

Low-fat, vegan dietBEHAVIORAL

Participants in the intervention group will be asked to follow a low-fat, vegan diet for the full 16 weeks of the study. They will also be guided to favor foods with a low glycemic index. The diet consists of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Animal products, added oils, and added sugars will be excluded.

Low-fat, vegan diet
ControlBEHAVIORAL

Participants assigned to the control group will be instructed to follow their usual diets for the full 16 weeks of the study.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female gender
  • Mild, moderate, or severe acne, as indicated by an Evaluator Global Severity Score (EGSS) score of 2, 3, or 4
  • Presence of at least 10 inflammatory or 20 non-inflammatory lesions on the face
  • Presence of acne for at least 3 months (by volunteer's history)
  • Age at least 18 years
  • Ability and willingness to participate in all components of the study
  • Willingness to be assigned randomly to a low-fat, vegan diet or a control group
  • Intention to remain in the Washington DC area for the 16-week study period.

You may not qualify if:

  • Change in use or dosage of hormone-based contraceptives in the last 3 months or anticipated change during the study period.
  • Use of depot medoxyprogesterone contraception
  • Use of oral retinoids in the last 6 months
  • Use of high doses of vitamin A in the last 3 weeks (≥ 10,000 IU)
  • Use of oral antibiotics or topical antibacterial or retinoid agents in the last 1 month
  • Presence of more than two nodules or cysts on the face or more than two nodules or cysts on the back and chest.
  • Use of medications known to cause or exacerbate acne including lithium, oral or injected steroids, or medications containing iodides or bromides
  • History of alcohol abuse or dependency followed by any current use
  • Current or unresolved past drug or alcohol abuse
  • Facial hair that would interfere with making acne assessments
  • Pregnancy or breastfeeding (currently or in the past 3 months), or intent to become pregnant in the next 4 months
  • History of severe mental illness within the past 3 years
  • Unstable medical status
  • Current dietary pattern that is low-fat and vegan
  • Anticipated difficulty attending or participating in group sessions
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington Center for Clinical Research

Washington D.C., District of Columbia, 20016, United States

Location

Related Publications (1)

  • Spencer EH, Ferdowsian HR, Barnard ND. Diet and acne: a review of the evidence. Int J Dermatol. 2009 Apr;48(4):339-47. doi: 10.1111/j.1365-4632.2009.04002.x. No abstract available.

    PMID: 19335417BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Diet, Fat-RestrictedDiet, Vegan

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDiet, VegetarianDiet, Plant-Based

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2009

First Posted

May 13, 2009

Study Start

July 1, 2009

Primary Completion

November 1, 2009

Study Completion

March 1, 2010

Last Updated

August 7, 2012

Record last verified: 2012-08

Locations

US(1)